Edgewise to advance heart drug EDG-7500 into Phase 3 following mid-stage HCM data update

Edgewise Therapeutics has released positive top‑line results from the 12‑week Phase 2 CIRRUS‑HCM trial of its oral cardiac sarcomere modulator EDG‑7500 for hypertrophic cardiomyopathy (HCM).

EDG‑7500 produced clinically meaningful improvements in hemodynamics, NT‑proBNP, KCCQ scores, NYHA class, and diastolic parameters in both obstructive (oHCM) and non‑obstructive (nHCM) patients, with no clinically meaningful reductions in left ventricular ejection fraction (LVEF) below 50%.

The drug was generally well tolerated in 53 patients, with nearly all adverse events mild to moderate; there were two new‑onset atrial fibrillation events, both assessed as unrelated to treatment.

Based on these results, Edgewise plans to advance EDG‑7500 into a pivotal Phase 3 program in HCM, with the first patient enrollment targeted for the fourth quarter of 2026.